CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
FDA 510(k) clearance K063647 · decided 2007-03-12
Clearance details
- K-number
- K063647
- Device name
- CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
- Applicant
- Thermo Electron OY
- Decision
- Substantially Equivalent
- Date received
- 2006-12-07
- Decision date
- 2007-03-12
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- NDY
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Vantaa, FI
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Thermo Electron OY
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.